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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT03362801 Recruiting - Bladder Cancer Clinical Trials

SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

SAMPHYR
Start date: October 30, 2017
Phase: N/A
Study type: Interventional

Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy. According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry). This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study. The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter. Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication. Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization

NCT ID: NCT03333356 Recruiting - Clinical trials for Patients With High-risk MIBC

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)

Bladder-ART
Start date: April 19, 2018
Phase: N/A
Study type: Interventional

This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection. The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment.

NCT ID: NCT03331705 Recruiting - Bladder Tumor Clinical Trials

Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures

Start date: November 5, 2016
Phase: N/A
Study type: Observational

This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.

NCT ID: NCT03317158 Recruiting - Bladder Cancer Clinical Trials

Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder

ADAPT-BLADDER
Start date: November 21, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to combination regimen cohorts will proceed. Cohorts will simultaneously enroll in parallel to each other with patients assigned to cohorts based on patient slot availability and study site choice of radiation arm participation. Patient assignment to future phase 1 arms would proceed similarly. Within BCG-containing cohorts, treatment will begin at full-dose BCG. If DLT criteria outlined in Section 5.1.4 are exceeded with full-dose BCG, a one level dose reduction of BCG will be implemented. If DLT criteria outlined in Section 5.1.4 are exceeded with reduced-dose BCG, the BCG-containing cohort will not proceed to Phase 2 of the study. Similarly, if DLT criteria outlined in Section 5.1.4 are exceeded within non-BCG containing cohorts, the non-BCG containing cohort will not proceed to phase 2 of the study. Due to the prolonged half-life of antibody therapies, no dose adjustments are planned for durvalumab in any of the cohorts.

NCT ID: NCT03301493 Recruiting - Clinical trials for Hematologic Neoplasms

Genomic Testing and Resulting Medical Decisions

Start date: March 30, 2017
Phase:
Study type: Observational [Patient Registry]

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

NCT ID: NCT03296306 Recruiting - Bladder Cancer Clinical Trials

Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma

FOCUS
Start date: September 2016
Phase: Phase 3
Study type: Interventional

The objective is to show non-inferiority of overall survival between four cycles and six cycles of first-line cisplatin based chemotherapy to determine the optimal duration of chemotherapy in patients with advanced urothelial carcinoma.

NCT ID: NCT03221829 Recruiting - Bladder Tumor Clinical Trials

A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients

Start date: July 6, 2017
Phase: N/A
Study type: Observational

The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.

NCT ID: NCT03216525 Recruiting - Bladder Cancer Clinical Trials

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo.

NCT ID: NCT03193970 Recruiting - Bladder Cancer Clinical Trials

Measuring Surgical Recovery After Radical Cystectomy

Start date: April 30, 2015
Phase:
Study type: Observational [Patient Registry]

The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

NCT ID: NCT03193788 Recruiting - Bladder Cancer Clinical Trials

Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

PREMIER
Start date: January 2017
Phase: Phase 3
Study type: Interventional

This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.